Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients.

Objective: To avoid over-treatment of low-risk prostate cancer patients, it is important to identify clinically significant and insignificant cancer for treatment decision-making. However, no accurate test is currently available. Methods: To address this unmet medical need, we developed a novel gene classifier to distinguish clinically significant and insignificant cancer, which were classified based on the National Comprehensive Cancer Network risk stratification guidelines. A non-invasive urine test was developed using quantitative mRNA expression data of 24 genes in the classifier with an algorithm to stratify the clinical significance of the cancer. Two independent, multicenter, retrospective and prospective studies were conducted to assess the diagnostic performance of the 24-Gene Classifier and the current clinicopathological measures by univariate and multivariate logistic regression and discriminant analysis. In addition, assessments were performed in various Gleason grades/ISUP Grade Groups. Results: The results showed high diagnostic accuracy of the 24-Gene Classifier with an AUC of 0.917 (95% CI 0.892-0.942) in the retrospective cohort (n = 520), AUC of 0.959 (95% CI 0.935-0.983) in the prospective cohort (n = 207), and AUC of 0.930 (95% 0.912-CI 0.947) in the combination cohort (n = 727). Univariate and multivariate analysis showed that the 24-Gene Classifier was more accurate than cancer stage, Gleason score, and PSA, especially in the low/intermediate-grade/ISUP Grade Group 1-3 cancer subgroups. Conclusions: The 24-Gene Classifier urine test is an accurate and non-invasive liquid biopsy method for identifying clinically significant prostate cancer in newly diagnosed cancer patients. It has the potential to improve prostate cancer treatment decisions and active surveillance.

Effect of a novel botanical agent Drynol Cibotin on human osteoblast cells and implications for osteoporosis: promotion of cell growth, calcium uptake and collagen production.

Osteoporosis is a widespread problem afflicting millions of people. Drynol Cibotinis is a newly developed proprietary botanical combination of eight botanicals including Angelica sinensis, Glycine max, Wild yam, Ligustrum lucidum, Astragalus membranaceus, Cuscuta chinensis, Psoraleae corylifoliae, and Drynaria fortune. Each of the botanicals has been used in traditional Chinese medicine to treat osteoporosis. The effect of Drynol Cibotinis, with the specific combination of these anti-osteoporosis botanicals for promoting bone growth, was examined in this study. The effects of Drynol Cibotin on cell growth, apoptosis, cell spreading, calcium uptake and production of bone matrix proteins Collagen I and Laminin B2 on human osteoblast cells were assessed by BrdU incorporation, TUNEL assay, cell staining, intracellular Ca2+ measurement and Western blot analysis. The results showed that Drynol Cibotin significantly increased cell proliferation and inhibited apoptosis in osteoblasts (P < 0.01). In addition, Drynol Cibotin was found to promote cell spreading and greatly increase calcium uptake both instantaneously and in the long term (P < 0.01). Furthermore, Drynol Cibotin significantly increased production of two key extracellular matrix proteins in bone cells: Collagen I and Laminin B2. These results indicate that Drynol Cibotin alone or in combination with amino acids and vitamins may have prophylactic potentials in osteoporosis.